BS EN ISO 7405:2018

What is ISO 7405- Biocompatibility of medical devices used in dentistry about?

ISO 7405 is an international standard on dentistry that discusses the evaluation of biocompatibility of medical devices. ISO 7405 provides methods for the efficient evaluation of biocompatibility of medical devices to ensure the protection of patients from harmful hazards.

ISO 7405 layouts test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

ISO 7405 contains special tests, for which ample experience exists in dentistry and which acknowledge the special needs of dentistry.

Note1: ISO 7405 does not cover the testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Note2: ISO 7405 does not explicitly describe test methods for occupationally related risks.

Who is ISO 7405- Biocompatibility of medical devices used in dentistry for?

ISO 7405 on evaluation of biocompatibility of medical devices used in dentistry is useful for:

• Medical device manufacturers
• Test centers for dentistry
• Regulatory authorities

Why should you use ISO 7405- Biocompatibility of medical devices used in dentistry?

Animal and clinical screening is necessary to protect patients from possible hazards presented by dental medical devices and new biological restorative treatments. These are because there are few realistic models to replace these forms of biocompatibility screening.

The need for biocompatibility materials for use in restorative dentistry and endodontics has generated a requirement for cytotoxicity assays to screen compounds and characterize the potentially harmful effects of material to oral tissues before clinical use.

ISO 7405 guideline assists you with the categorization of medical devices, biological evaluation process, and test procedures on agar diffusion test, filter diffusion test, pulp and dentine usage test, pulp capping test, and endodontic usage test specific to dental materials.

This assists in the proper assessment of medical devices used in dentistry and evaluating the biocompatibility of medical devices used in dentistry.

With compliance and obedience to ISO 7405, you can ensure the efficient compatibility of medical devices in dentistry and prevent harmful hazards due to the incompatibility of medical devices.

What’s changed since the last update?

This third edition of ISO 7405 cancels and replaces ISO 7405:2008 and ISO/TS 22911:2016 which have been technically revised. It also incorporates the Amendment ISO 7405:2008/Amd.1:2013. The main changes compared to the previous edition are as follows:

• As a crucial first step in the biological evaluation, a material characterization is required before biological tests are conducted (see 5.4.2)
• Modifications of contents of ‘pulp and dentine usage test’ and ‘endodontic test’
• Addition of ISO/TS 22911 as a new annex c